Kornimate/medical-research-clean huggingface dataset:
assessment of antibody persistence in children previously vaccinated with pneumococcal conjugate vaccine

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines

Summary: this protocol posting deals with objectives \& outcome measures of the extension phase up to 48-50 months post booster vaccination, to assess long-term antibody persistence in children at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal conjugate vaccine. the objectives \& outcome measures of the primary phase are presented in a separate protocol posting (nct number = 00307554). this protocol posting has been updated in order to comply with the fda aa (sep 2007).

this study consists in a serological follow-up study to evaluate persistence 12, 24 and 48 months after the booster vaccination study (107046). no study vaccines will be administered within this study.

Eligibility criteria:
inclusion criteria: * male or female between, and including, 28-30 months of age at the time of first blood sampling. * subjects who previously participated in the 105553 and 107046 studies and who received a full four dose regimen of pneumococcal conjugate vaccine during the primary and booster studies. * subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * written informed consent, covering visits 1, 2 and 3, obtained from the parent or guardian of the subject. * free of obvious health problems as established by medical history and clinical examination before entering into the study. exclusion criteria: * chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the blood sampling * administration of any additional pneumococcal vaccine since end of 107046 study. * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling. * administration of immunoglobulins and/or any blood products less than 6 months prior to blood sampling. * any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 107046 study, based on medical history and physical examination.

Keywords: streptococcus pneumoniae haemophilus influenzae pneumococcal conjugate vaccine antibody persistence
different β -blockers in stemi and primary pci

Conditions: Primary PCI

Summary: carvedilol, target dose: 50 mg daily; bisoprolol, target dose: 10 mg daily; metoprolol tartrate, target dose: 150 mg daily; metroprolol succinate, target dose: 200 mg daily

the investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in stemi patients undergoing primary pci.

Eligibility criteria:
inclusion criteria: * admitted for primary pci for stemi involving the lad within 12 hours of onset of symptoms. stemi will be defined as typical ecg changes (st segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; * age ≥18 years; * informed consent from patient or next of kin. exclusion criteria: * nonischaemic cardiomyopathy; * cardiac surgery planed in the 6 months; * mechanical complication of stemi (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); * renal or hepatic failure; * malignancy, hiv, or central nervous system disorder; * cardiopulmonary resuscitation \>15 min and compromised level of consciousness; * cardiogenic shock; * current participation in any research study involving investigational drugs or devices; * no written consensus; * previous myocardial infarction.
amiodarone and n-acetylcysteine or amiodarone alone for preventing atrial fibrillation after thoracic surgery

Conditions: Thoracic Surgery; Atrial Fibrillation in High Risk Patients

Summary: this trial will be comparing the combination of amiodarone and nac (n=122) to amiodarone alone and nac matched placebo (n=122) to determine the rates with which sustained (lasting \>30 seconds) or clinically significant poaf is reduced in high risk patients within 7 days after major thoracic surgery.


Eligibility criteria:
inclusion criteria: * patients ≥18 years old scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria: * 1. female \& bnp ≥ 25pg/ml (no age limit) * 2. male gender \<75 \& bnp ≥ 25pg/ml * 3. male- age ≥75 (no bnp limit) * 4. history of prior af * patients in sinus rhythm. * patients with stable respiratory status (no respiratory distress). * patients capable of providing written, informed consent. exclusion criteria: * patients scheduled for extrapleural pneumonectomy. * hemodynamically unstable patients (not in cardiogenic shock or having an acute mi). * patients with 2nd or 3rd degree atrioventricular (av) block. * patients with hypersensitivity to amiodarone or nac. * patients already taking class ic or iii antiarrhythmic drugs. * hepatic insufficiency (≤2 times the upper normal limit of transaminase levels). * renal insufficiency (creatinine ≥2.0 mg/dl). * known pregnancy.

Keywords: amiodarone n-acetylcysteine 16-307
impact of liwen procedure in obstructive hypertrophic cardiomyopathy on arrhythmias

Conditions: Hypertrophic Cardiomyopathy; Arrhythmia

Summary: the goal of this observational study is to learn about the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during or after percutaneous intramyocardial septal radiofrequency ablation. the main questions it aims to answer are: * to investigate the occurrence of various arrhythmias ( tachyarrhythmia and bradyarrhythmia ) during procedure and its relationship with clinical characteristics and procedural parameters * to analyze the changes of 12-lead electrocardiogram and 24-hour dynamic electrocardiogram before and after percutaneous intramyocardial septal radiofrequency ablation and their relationships with clinical characteristics and procedural parameters


Eligibility criteria:
inclusion criteria: 1. subject with symptoms that limit daily activities (new york heart association functional class \>ii, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated 2. subject with a peak lvot gradient≥50 mm hg 3. subject volunteers for the liwen procedure and received the procedure at the hypertrophic cardiomyopathy center of xijing hospital. exclusion criteria: 1. subject with a peak instantaneous doppler lvot gradient of \<50 mm hg 2. subject with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention) 3. subject has end-stage heart failure
retrospective, non-interventional natural history of patients with juvenile-onset hypophosphatasia (hpp)

Conditions: Hypophosphatasia (HPP)

Summary: the purpose of this study is to characterize the natural history of hpp in patients with juvenile-onset hpp.

hypophosphatasia (hpp) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. there are no approved disease-modifying treatments for patients with this disease. there is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria:
inclusion criteria: * documented informed consent unless patient is deceased * patients with juvenile-onset hpp, defined as documented onset of first signs/symptoms at ≥ 6 months to ˂18 years * documented diagnosis of hpp as indicated by skeletal manifestations and low alkaline phosphatase or genotyping exclusion criteria: * received treatment with asfotase alfa in the enb-006-09 study and/or currently enrolled in the enb-008-10 study * received other treatment and/or intervention to treat hpp up to 15 years old * other clinically significant disease

Keywords: hypophosphatasia hpp bone disease soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase tissue non-specific alkaline phosphatase rickets osteomalacia
retrospective study on the safety and therapeutic/improvement effects of intravenous administration of shed-cm for als (shed-cah2023)

Conditions: Amyotrophic Lateral Sclerosis

Summary: in this study, we will retrospectively evaluate the safety and efficacy of administering shed-cm for the treatment of als.

amyotrophic lateral sclerosis (als) is a progressive and irreversible neurodegenerative disease with limited treatment options. advances in regenerative medicine have opened new avenues for therapeutic interventions. this retrospective cohort study evaluated the safety and efficacy of stem cells from human exfoliated deciduous teeth-conditioned media (shed-cm) in 24 patients with als treated at a single facility between january 1, 2022, and november 30, 2023. safety assessments included adverse events, vital signs, and laboratory test changes before and after administration, whereas efficacy was measured using the als functional rating scale-revised (alsfrs-r), grip strength, and forced vital capacity. while alsfrs-r scores typically decline over time, the progression rate in this cohort was slower, suggesting a potential delay in disease progression. alternatively, improvements in muscle strength and mobility were observed in some patients. although adverse events were reported in only 3% of cases (no serious allergic reactions), the treatment-induced changes in vital signs and laboratory results were not clinically significant. the shed-cm treatment appears to be a safe and potentially effective therapeutic option for patients with als. further research is needed to optimize the shed-cm treatment; however, this study lays the groundwork for future exploration of regenerative therapies for als.

Eligibility criteria:
inclusion criteria: * patients who visited our clinic between january 1, 2022 and november 30, 2023 and have been diagnosed with als * male and female patients aged between 16 and 90 years old * alsfrs-r score of 12 or more at the time of initial visit exclusion criteria: * patients who have a tracheostomy at the time of visit. * patients who have expressed their refusal to participate in this study.

Keywords: als - amyotrophic lateral sclerosis stem cells conditioned medium therapy safety regenerative medicine
natural dentition, prosthesis and antagonist wear 3d analysis

Conditions: Wear, Tooth; Dental Prosthesis Complication; Wear, Occlusal

Summary: wear resistance is one of the most important physical properties of teeth, and wear resistance of zirconia against artificial acrylic, enamel and composite resin denture teeth has not been clearly established. implant-supported dental restorations present a higher threshold for occlusion perception when compared to natural teeth, which can occlusal overload mechanisms or lead to wear of rehabilitation materials or the antagonist arch. in clinical conditions, however, many other factors influence the complex interaction between dental enamel and opposing substrates: patient-related factors such as dietary habits, dysfunctional occlusion, masticatory forces, and bruxism contribute to accelerated enamel loss of antagonist teeth.

it will be our intention to perform a prospective study and proof-of-concept to assess wear in natural dentition, full arch implant supported rehabilitation (faisr) and opposing arches. wear according to type of rehabilitation and of opposing arch, technical complications, parafunction and number of placed implants will be assessed. intra-oral digital acquisition will be performed at pre-defined intervals. changes over time will be assessed through a previously described digital superimposition methodology volumetric changes determined. patients will be scanned using an intraoral dental scanner (t0) patients will be recalled at every 4-months (t1), 8-months (t2) and 12-months (t3) visits for re-scanning and from there every 6-months scanned images will be compared using a metrology software to determine maximum vertical wear of teeth and root mean square wear.

Eligibility criteria:
dentate group : inclusion criteria * fully dentate (with at least 10 teeth ) and do not have any tooth mobility; * at least 12months follow up exclusion criteria - missing more than 4 teeth, extensive caries, bonded orthodontic brackets edentulous group: inclusion criteria: * maxilla or mandible implant full-mouth implant restoration * monolithic ceramic or hybrid-acrylic restoration * at least12 months follow-up exclusion criteria: * heavy bruxists * patients that changed the full arch rehabilitation during the study (ex: framework fracture or lab reparation)

Keywords: tooth wear full arch implant 3d scanner prosthesis screw retained zirconia hybrid acrylic
remotely supervised exercise therapy trial 2

Conditions: Claudication, Intermittent; Peripheral Arterial Disease

Summary: supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the national institute for health and clinical excellence and the european society for vascular surgery. however 2/3 of british trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing. during the covid-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist. reset2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.

design a single centre, pilot, randomised controlled trial at mid and south essex hospitals foundation trust. the study is unfunded and sponsored by mid and south essex hospitals national health service trust. sample size this is a pilot randomised controlled trial to generate a sample size calculation for a larger trial. based on the feasibility data from reset1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups. with alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (medcalc statistical software, belgium). the sample size will be 20+20 patients from mid and south essex trust vascular outpatient clinics. follow up there will be 3 assessment visits: baseline, 3 months and 6 months performed with a study clinician. the primary endpoint will be measured blind to treatment allocation by asking the patient to walk along a flat, hospital corridor until they need to stop due to leg pain. this will be measured at 0, 3 and 6 months. the secondary endpoint will be through patient questionnaires and scored by an independent observer at baseline, 3 and 6 months. ankle-brachial pressure index will be measured by an independent vascular scientist at the start and end of the study. patient satisfaction will be measured at 3 months using a self-reported questionnaire. adherence to exercise will be measured through submission of walking logs at 1, 2 and 3 months.

Eligibility criteria:
inclusion criteria: * arterial claudication with abpi \ 20mmhg * able to walk 50 metres unaided * willing to try and give up smoking * willing to take antiplatelet, rivaroxaban and statin * has a smartphone or pedometer or watch * has an email account * adult \> 18 years old * able to give informed consent exclusion criteria: * nocturnal foot pain or tissue loss * use of walking stick, frame or wheelchair * severe copd or heart failure or arthritis * home oxygen * major amputation and non-limb wearer * severe hearing or visual impairment * prior failed exercise regime * prior falls * cognitive impairment * unable to work due to severity of claudication
a study of eur-1066 in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain

Conditions: Chronic Pancreatitis

Summary: the purpose of this study is to evaluate two different treatments in subjects with chronic pancreatitis, exocrine pancreatic insufficiency and chronic abdominal pain.

to evaluate two different preparations of a pancreatic enzyme in subjects with chronic pancreatitis, exocrine pancreatic insufficiency, and chronic abdominal pain.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic pancreatitis * exocrine pancreatic insufficiency * chronic abdominal pain exclusion criteria: * acute pancreatitis * active alcohol consumption * uncontrolled diabetes

Keywords: chronic abdominal pain exocrine pancreatic insufficiency
metformin treatment of pregnant women with polycystic ovary syndrome: a pilot study

Conditions: Polycystic Ovary Syndrome

Summary: to investigate the effect of metformin on pregnancy complications and pregnancy outcome in the ii. and iii. trimester of pregnancy in women with polycystic ovary syndrome.


Eligibility criteria:
inclusion criteria: * diagnosis polycystic ovary syndrome (pcos ) before pregnancy * bmi 27-40 kg/m2 * human chorionic gonadotropin, beta subunit (hcg-beta) verified pregnancy week 5-8 * at least one of the following criteria: (1) serum testosteron \> 2,5 nmol/l; (2) sex hormone binding globulin (shbg) \ 1,0 nmol/l; (4) menstrual disturbances: oligo-/amenorrhea or metrorrhagia; (5) hirsutism exclusion criteria: * known liver disease or alat \> 60 iu/l * s-creatinin \> 130 micromol/l * diabetes mellitus * alcohol or drug abuse * peroral steroid treatment (except inhalation steroids) * use of cimetidine, anticoagulant, erythromycin or other macrolides * not suitable for other reasons

Keywords: metformin pregnancy outcome androgens
observational patient diary study of treatment doses for patients with haemophilia with inhibitors to factors viii and ix

Conditions: Congenital Bleeding Disorder; Haemophilia A With Inhibitors; Haemophilia B With Inhibitors

Summary: this study is conducted in the united states of america (usa). the aim of this study is to investigate the at-home-administration of bypassing agents for treatment of bleeding episodes in patients with congenital haemophilia with inhibitors to factors viii and ix. we are further investigating how bleeding episodes affect the quality of life of the patient and their family or caregivers.


Eligibility criteria:
inclusion criteria: * male subjects with congenital haemophilia a or b and inhibitors with spontaneous bleeds which require on-demand treatment * subjects prescribed novoseven® as the first line or recommended bypass agent * history of on average at least 4 bleeds of any type over a 3 month period * subject or caregiver able and willing to complete daily journal for 3 months * informed consent obtained from all subjects or legal representative
nutrition therapy in the immature infant (imnut)

Conditions: Immature Infant; Essential Fatty Acid Deficiency

Summary: the primary objective of this double-blind randomized study is to assess the effects of an early, enhanced supply of the essential fatty acids (fas) arachidonic acid (ara) and docosahexaenoic acid (dha) on brain maturation, clinical outcomes and quality of growth in immature infants (gestational age \<29 weeks) as compared to standard nutrient supply.

this is a double-blind randomized study. 172 preterm infants with gestational age \< 29 weeks will be enrolled. the intervention group will receive enteral supplementation with essential fatty acids, arachidonic acid (ara) and docosahexaenoic acid (dha). the control group will receive standard supplementation with medium-chain triglycerides (mct-oil). the main hypothesis is that early, enhanced supply of ara and dha will improve brain growth and maturation, as compared to standard nutrient supply. secondary hypotheses are that early, enhanced supply of ara and dha will improve quality of growth and cognitive development as well as reduce the frequency of inflammation-related neonatal comorbidities and long-term cardiovascular disease risk. primary endpoint will be assessed by magnetic resonance imaging (mri) of the brain at term equivalent age.

Eligibility criteria:
inclusion criteria: * extremely preterm infants born at oslo university hospital (ouh) * gestational age (ga) \< 29 weeks * less than 48 hours of age at inclusion * signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to good clinical practice (gcp) and national/local regulations exclusion criteria: * major congenital malformations which will affect growth and development * chromosomal abnormalities and other genetic diseases * critical illness with short life expectancy as defined by the study physician

Keywords: brain maturation postnatal growth
clinical evaluation of [177lu]lu-bq7876 for targeting of prostate-specific membrane antigen

Conditions: Prostate Cancers

Summary: the study should evaluate the biological distribution of \[177lu\]lu-bq7876 in patients with prostate cancer. the objective are: 1. to evaluate the content of \[177lu\]lu-bq7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration. 2. to assess the distribution of \[177lu\]lu-bq7876 in normal tissues and tumors at different time points. 3. to evaluate dosimetry of \[177lu\]lu-bq7876. 4. to study the safety and tolerability of the drug \[177lu\]lu-bq7876 after a single injection.

the overall goal is to study the effectiveness of prostate-specific membrane antigen targeting using lutetium-177 - labeled bq7876. phase i of the study: biodistribution, dosimetry, safety and tolerability of \[177lu\]lu-bq7876 in patients with prostate cancer. the main objectives of the study: 1. to evaluate the content of \[177lu\]lu-bq7876 in the blood of patients with prostate cancer at different time points after a single intravenous administration. 2. to evaluate the distribution of \[177lu\]lu-bq7876 in normal tissues and tumors in patients with prostate cancer at different time points after a single intravenous administration. 3. to evaluate dosimetry of \[177lu\]lu-bq7876 based on the pharmacokinetic parameters of the drug after a single intravenous administration. 4. to study the safety of use and tolerability of the drug \[177lu\]lu-bq7876 after a single intravenous administration in a diagnostic dosage. methodology: open-label, exploratory, single centre study. the subjects will receive a single injection of the labeled tracer.

Eligibility criteria:
inclusion criteria: * subject is \> 18 years of age * clinical and radiological diagnosis of prostate cancer with histological verification. * white blood cell count: \> 2.0 x 10\^9/l * haemoglobin: \> 80 g/l * platelets: \> 50.0 x 10\^9/l * bilirubin =\< 2.0 times upper limit of normal * serum creatinine: within normal limits * blood glucose level not more than 5.9 mmol/l * subject is capable to undergo the diagnostic investigations to be performed in the study * informed consent exclusion criteria: * active current autoimmune disease or history of autoimmune disease * active infection or history of severe infection within the previous 3 months (if clinically relevant at screening) * known hiv positive or chronically active hepatitis b or c * administration of other investigational medicinal product within 30 days of screening * ongoing toxicity \> grade 2 from previous standard or investigational therapies, according to us national cancer institute's

Keywords: prostate-specific membrane antigen prostate cancers [177lu]lu-bq7876 radioligand therapy